Forehead support for facial mask

ABSTRACT

A pad for a forehead support includes an outer wall having a first side configured to engage a user&#39;s forehead and a second side having engaged surfaces configured to rest against engaging surfaces of the forehead support; at least one retaining wall provided between the first side and the second side; and at least one retained portion configured to be retained by a retainer formed on the forehead support, wherein a space is defined between the outer wall and the engaged surfaces. The space has a substantially constant cross sectional profile, and the outer wall, the at least one retaining wall, and the engaged surfaces are formed of a deformable elastomeric material. Deformation of the pad occurs by deflection of at least the outer wall and the at least one retaining wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/207,006, filed Aug. 19, 2005, now allowed, which is a continuation ofU.S. application Ser. No. 10/661,570, filed Sep. 15, 2003, now U.S. Pat.No. 6,997,188, which is a continuation of U.S. application Ser. No.10/230,169, filed Aug. 29, 2002, now U.S. Pat. No. 6,691,708, which is adivisional of U.S. application Ser. No. 09/608,440, filed Jun. 30, 2000,now U.S. Pat. No. 6,463,931, which is a continuation of U.S. applicationSer. No. 09/008,708, filed Jan. 16, 1998, now U.S. Pat. No. 6,119,693,each incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to an improved comfort device tobe used with a nasal mask. In particular, the device is useful incombination with masks which are used for the treatment of respiratoryconditions and assisted respiration. The invention assists in fittingthe mask to the face as well.

BACKGROUND OF THE INVENTION

Nasal masks are commonly used in the treatment of respiratory conditionsand sleep disorders by delivering a flow of breathable gas to a patientto either assist the patient in respiration or to provide a therapeuticform of gas to the patient to prevent sleep disorders such asobstructive sleep apnea. These nasal masks typically receive a gasthrough a supply line which delivers gas into a chamber formed by wallsof the mask. The mask is generally a semi-rigid mask which has a faceportion which encompasses at least the wearer's nostrils. Additionally,the mask may be a full face mask. The mask is normally secured to thewearer's head by straps. The straps are adjusted to pull the maskagainst the face with sufficient force to achieve a gas tight sealbetween the mask and the wearer's face. Gas is thus delivered to themask through the aperture to the wearer's nasal passages and/or mouth.

One of the problems that arises with the use of the mask is that inorder for the straps to be tight, the mask is compressed against thewearer's face and may push unduly hard on the wearer's nose.Additionally, the mask may move around vis-á-vis the wearer's face.Thus, there has been provided a forehead support, which provides asupport mechanism between the mask and the forehead. This foreheadsupport prevents both the mask from pushing too strongly against thewearer's nose and/or facial region as well as minimize movement of themask with the addition of a contact point between the mask and thewearer's head as well as minimize uncomfortable pressure points of themask. Additionally, the forehead support may prevent the air flow tubefrom contacting the wearer's forehead or face.

Prior to the present invention, the forehead supports were generally asingle cushion with a single contact point which may be adjustable byrotation of a screw, with the single cushion pushing on the forehead ata single point. This is oftentimes uncomfortable for the patient, andthe adjustability of the distance of the pad for different foreheadprotuberances oftentimes was difficult if not impossible to beperformed. Additionally, a single contact point does not providenecessary lateral support to the mask. Finally, a single contact pointmay apply too much pressure at the single point.

Examples of prior art nasal masks are shown in U.S. Pat. Nos. 4,782,832and 5,243,971.

There is a need for an improved forehead support for nasal and facialmasks which adjusts to different angles on the face.

There is a need for a forehead support for nasal masks which may beadjusted to different forehead shapes.

There is a need for a multi-point forehead support for nasal masks.

These and other advantages will be described in more detail below.

SUMMARY OF THE INVENTION

The present invention is directed to an improved forehead support fornasal and facial masks. In particular, the present invention utilizes adual cantilevered forehead-support which preferably utilizes dualcontacts which are arranged at an obtuse angle with respect to oneanother and which may be easily adjusted for different foreheadprotuberances. Preferably, the forehead support has two arms extendingfrom the mask or gas supply line, with the two arms engagable into abridge system wherein the arms may be adjusted to different positions onthe bridge allowing optimal positioning of the mask on the face. Thisachieves even pressure of the mask on the face. The mask also providesan excellent fit which limits movement of the mask during sleep. Theforehead support is adjustable such that the support is closer orfurther away from the front plane of the facial mask. The bridgesupports the pad or pads which contact the wearer's forehead. Thesupport also may allow the mask to be secured such that more pressure isapplied to one area of the mask, to seal a leak for example.

The present invention allows the mask user to adjust the angle of themask to the face. This is possible due to the two point contact of theforehead support to the forehead working in combination with the pointof contact of the mask to the face. The system thus has three points ofcontact, wherein the forehead pads provide two contact points and themask to the face is a third point of contact. Adjusting the angle of theforehead pads or the distance of the legs to the forehead pads adjuststhe angle of the mask vis-á-vis the face of the user. This unique systemprovides a mask system which can be adjusted to fit the different faceangles or profiles required by users.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the forehead support of the presentinvention attached to a mask, headgear and a gas supply tube.

FIG. 2 is a perspective view of the forehead support of the presentinvention removed from the mask and gas line.

FIG. 3 is an exploded view of the forehead support of the presentinvention.

FIG. 4 is a side view of the present invention secured to a mask.

FIG. 5 is a top view of the forehead support of the present invention ina first position.

FIG. 6 is a top view of the forehead support of the present invention ina second position.

FIG. 7 is a top view of the forehead support of the present invention ina 15 third position.

FIG. 8 is a top view of the forehead support of the present invention ina fourth position.

FIG. 9 is a front view of the bridge of the present invention.

FIG. 10 is a single pad of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a general perspective view of the forehead support 10 ofthe present invention. The forehead rest or support 10 is attached to anextending airflow tube 12 from the mask 14. The mask 14 and foreheadsupport 10 are shown with headgear 16 which secures the mask 14 to thehead of a patient. The headgear 16 may take a variety of forms, with oneexample being shown as 16. As can be seen in FIG. 1, preferably theheadgear 16 loops through the forehead support 10 at 18 and 20. Thispulls the forehead support 10 against the forehead, thus creating asnugly fitted mask 14 and also provides a stabilizing member for themask 14.

The mask 14, shown in FIG. 1 is merely one example of a mask which canbe used with a forehead support, but any respiratory mask could be used.A fill face mask which may cover the entire face or just both the noseand mouth could be used, for example. Additionally, the airflow tube 12could be extending from the bottom of the mask 14, thus the tube 12supporting the forehead support 10 would terminate above foreheadsupport 10. If the airflow tube 12 extended in a downward or otherdirection from the mask 14, then preferably a post would extend up fromthe mask 14 (this post position is referenced as 22). This post 22 wouldterminate slightly above where forehead support 10 is shown secured totube 12. Thus the forehead support 10 would be secured to the post inthis alternative embodiment.

FIG. 2 discloses the preferred construction of the forehead support 10of the present invention. The forehead support 10 has pads 24 and 26.These pads 24 and 26 are the actual contact points of the foreheadsupport 10 to the forehead. Pads 24 and 26 are preferably made of adeformable elastomeric material which retains its original shape uponrelease of pressure and provides the wearer with increased comfort andstability. As can be seen in the preferred embodiment, the forehead pads24 and 26 have an annular interior construction with two retaining walls28 and 30. The retaining walls 28 and 30 provide structural-integrity tothe forehead contact support pads yet allow the pads to be deformed. Thedeformation preferably occurs by deflection of the pad walls. The padsalso may be solid pads. The support pads 24 and 26 are mounted to thebridge 32. The bridge 32 provides basically three purposes to theforehead 10 support 10. First off, it acts as a securing means forforehead pads or cushions 24 and 26. Second of all, it has annularspaces 18 and 20 which receive the optional headgear 16 shown in FIG. 1.Finally, it receives arms 34 and 36, which may be adjusted, as describedbelow. The bridge 32 and arms 34 and 36 operate in a cantilever fashionand are preferably made of a polymeric material, which may be easilymolded, preferably injection molded. Arms 34 and 36 are secured tobridge 32 by an adjustable locking mechanism which is better illustratedin the figures below. Additionally, arms 34 and 36 join together tocreate an annular space 38 which may receive airflow tube 12 which ispreferably connected to a flow generator to generate breathable air orsome type of therapeutic gas. Arms 34 and 36 preferably create anoperational hinge. The tube 12 may be an axis of this hinge. The hingecould also be a flexible membrane and not a rotational or axial hinge.Alternatively, the tube may extend through annular space 38 andterminate as described above (in the “post” embodiment) if the air flowtube is connected to another port on the mask.

FIG. 3 is an exploded view of FIG. 2 and shows the forehead support 10in greater detail. FIG. 3 discloses how bridge 32 is configured suchthat forehead pads 24 and 26 may be secured thereto. In particular,tongues 40, 42, 44 and 46 all engage forehead pads 24 and 26 by enteringthe interior space of the pads. This is shown in FIG. 2 wherein tongues42 and 46 are shown securing pads 24 and 26 respectively by entering theannular space of the pads 24 and 26. Additionally, there may be engagingsurfaces such as 48, 50, 52 and 54, as shown in FIG. 3, which engage aninner side wall of forehead pads 24 and 26. The means by which theforehead pads are secured to the bridge 32 can be done in many manners,and one skilled in the art can come up with numerous methods ofachieving this securement. Two sided tape may be used, protruding pegsand apertures on the forehead pad may be used or many other methods.What is desirable is that the forehead pad(s) may be replaced afterextended use or, in a clinical setting, with each new patient. Themethod of securement of the pad(s) to the support is not a limitingfeature of the present invention.

The type of forehead pad may also vary, it may include a solid foam 15sponge, a stuffed pad, a dual durometer foam which may be a single pador multiple pads attached together, or many other known pads which wouldimpart comfort when placed directly on the forehead. Finally, a singlepad which extends all the way across bridge 32 may be used or more thantwo pads may be used.

Bridge engaging pins 56, 58, 60 and 62 are shown in FIG. 3. As will be20 more apparent in the figures below, these engaging pins provide forthe adjustability of the forehead support 10 of the present invention.There are pin receiving means located on the bridge 32 which receivepins 56, 58, 60 and 62. The pins 56, 58, 60 and 62 are merely oneexample of how the arms 34 and 36 may be secured to bridge 32. There areother designs which would work just as well as the pin designs. Suchdesigns are known to those skilled in the art. Additionally, there is aspace or recess at arms 34 and 36 shown clearly on arm 34 as 64. Thepurpose of this space 64 is so that the user may compress arm 34 andthus press 56 and 58 together by pressing on surfaces 66 and 68. Thepurpose of the compression is such that the distance between prongs 56and 58 is decreased and thereby they may be inserted and locked intobridge 32. The structure and method of this insertion will be describedin further detail below.

FIG. 4 is a side view of the mask 14 and forehead support 10 of thepresent invention. The mask is shown as 14 with a dotted line showingthe nose of a wearer 70 and the dotted line showing the forehead 72 ofthe wearer. Pad 26 is shown compressed by the forehead of the individualwearing the mask.

FIG. 5 is a top view of the forehead support 10 of the present inventiontaken along lines S of FIG. 4. Also, the mask 14 is not shown in FIG. 5.This figure illustrates the forehead support 10 in a position whereinthe forehead support is the closest to the tube 12 (shown as merely aspace in FIGS. 5-8). The bridge 32 is shown essentially in contact withtube 12. The pins 56, 58, 60 and 62 are shown in their furthest positionfrom the center of the bridge 32. This position may be utilized bysomeone with a large, protruding or bulbous forehead, or a high nasalbridge, or someone who prefers the airflow tube to be snug against theirforehead.

FIG. 6 shows the same forehead support in the next position, wherein thebridge 32 is moved away from tube 12 such that there is a gap 74 betweenbridge 32 and tube 12. As is visible from the figure, the foreheadsupport 10 is now moved further away from tube 12, and is positioneddifferently than in FIG. 5. This may be configured to fit someone with aless protruding forehead, or someone who wants the flexible tube furtherfrom their head than is possible in FIG. 5.

FIG. 7 and S show the third and fourth position for the forehead supportof the present invention. Although the present embodiment shows afour-positioned forehead support, the number of slots, shown as 76, 78,80, 82, 84 86, 88 and 90 may be varied. There may be more or fewerslots, or there may just be one single slot wherein pins 56 and 58slides transversely across bridge 32 and has locking recesses locatedalong the slide. Additionally, the adjustments do not have to beuniform. In other words, the right side may be adjusted to slot 88 wherethe left side may be adjusted to slot 84 for some particular patient.There may also be more slots or adjustments on one side of the bridge ascompared to the other side of the bridge. Finally, the arms may becoupled such that movement of just one arm moves the other arm in alikewise manner.

FIG. 9 shows an isolated view of bridge 32. The slots 76, 78, 82, 84,86, 15 88 and 90 are visible from this view. The slots are configuredsuch that prongs 56, 58, 60 and 62 may be inserted therein. There is amirror set of slots on the upper portion of bridge 32 which are notvisible in FIG. 9. Again, there can be additional slots, fewer slots, ordifferent methods of locking the arms 34 and 36 to various positionsalong the bridge 32. What is important to the present invention is thatthe bridge 32 with the accompanying pads 24 and 26 may be positioned toa variety of distances between the tube 12 and the pads 24 and 26.Additionally, the pad may be one continuous pad, three pads, five pads,four pads, etc. There also may a double bridge used, wherein there couldbe a total of two or more pads with two bridges.

FIG. 10 is a perspective view of the preferred forehead pad of thepresent invention. As indicated above, there could be many shapes orvariations of a forehead pad and type of forehead pad or the shape offorehead pad is not limited in the present invention.

It is to be understood that while the invention has been described abovein conjunction with preferred specific embodiments, the description andexamples are intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

1. A pad for a forehead support, comprising: an outer wall having afirst side configured to engage a user's forehead and a second sidehaving engaged surfaces configured to rest against engaging surfaces ofthe forehead support; at least one retaining wall provided between thefirst side and the second side; and at least one retained portionconfigured to be retained by a retainer formed on the forehead support,wherein a space is defined between the outer wall and the engagedsurfaces, the space comprises a substantially constant cross sectionalprofile, and the outer wall, the at least one retaining wall, and theengaged surfaces are formed of a deformable elastomeric material,wherein deformation of the pad occurs by deflection of at least theouter wall and the at least one retaining wall.
 2. A pad according toclaim 1, wherein the deformable elastomeric material retains its shape.3. A pad according to claim 1, wherein the cross sectional profile issubstantially constant along a length of the pad.
 4. A pad for aforehead support, comprising: an outer wall configured to contact auser's forehead, the outer wall having a first end and a second end; aninner wall extending between the first end and the second end of theouter wall, the inner wall being structured to be attached to theforehead support, and the outer wall being spaced from the inner wallbetween the first end and the second end so as to define an open space;and a first retaining wall and a second retaining wall extending betweenthe inner wall and the outer wall between the first end, wherein thefirst and second retaining walls divide the space into first, second andthird sub-spaces and the inner wall, the outer wall, the first retainingwall and the second retaining wall are formed of an elastomericmaterial, wherein deformation of the pad occurs by deflection of atleast the outer wall and at least one of the first retaining wall andthe second retaining wall.
 5. A pad according to claim 4, wherein atleast two of the sub-spaces have different cross sectional profiles. 6.A pad according to claim 4, wherein the inner wall has a varyingthickness.
 7. A pad according to claim 4, wherein the second sub-spaceis provided between the first and third sub-spaces, and the secondsub-space comprises at least one retained portion configured to beretained by at least one retainer formed on the forehead support.
 8. Apad according to claim 7, wherein the at least one retained portioncomprises two retained portions and the at least one retainer portioncomprises two retainer portions.
 9. A pad according to claim 4, whereinthe space comprises a constant cross sectional profile.
 10. A padaccording to claim 9, wherein the cross sectional profile issubstantially constant along a length of the pad.
 11. A pad according toclaim 4, wherein the pad is formed of a deformable elastomeric materialthat retains its shape.
 12. A forehead support for a respiratory mask,comprising: a bridge structured and configured to be positioned abovethe mask adjacent a user's forehead, the bridge including upper andlower pad engaging surfaces and at least one pad retainer between thepad engaging surfaces; and a forehead pad including an outer wall havinga first side configured to engage a user's forehead and a second sidehaving engaged surfaces configured to rest against the pad engagingsurfaces of the bridge, at least one retaining wall provided between thefirst side and the second side, and at least one retained portionconfigured to be retained by the at least one pad retainer on thebridge, wherein a space is defined between the outer wall and theengaged surfaces, the space comprises a substantially constant crosssectional profile, and the outer wall, the at least one retaining wall,and the engaged surfaces are formed of a deformable elastomericmaterial, wherein deformation of the pad occurs by deflection of atleast the outer wall and the at least one retaining wall.
 13. A foreheadsupport according to claim 12, wherein the deformable elastomericmaterial retains its shape.
 14. A forehead support according to claim12, wherein the cross sectional profile is substantially constant alonga length of the pad.
 15. A respiratory mask, comprising: a face contactportion configured to engage the patient's face; a forehead supportconnected to the face contact portion, the forehead support including abridge structured and configured to be positioned above the maskadjacent the patient's forehead, the bridge including upper and lowerpad engaging surfaces and at least one pad retainer between the padengaging surfaces; and a forehead pad including an outer wall having afirst side configured to engage a user's forehead and a second sidehaving engaged surfaces configured to rest against the pad engagingsurfaces of the bridge, at least one retaining wall provided between thefirst side and the second side, and at least one retained portionconfigured to be retained by the at least one pad retainer on thebridge, wherein a space is defined between the outer wall and theengaged surfaces, the space comprises a substantially constant crosssectional profile, and the outer wall, the at least one retaining wall,and the engaged surfaces are formed of a deformable elastomericmaterial, wherein deformation of the pad occurs by deflection of atleast the outer wall and the at least one retaining wall.
 16. Arespiratory mask according to claim 15, wherein the deformableelastomeric material retains its shape.
 17. A respiratory mask accordingto claim 15, wherein the cross sectional profile is substantiallyconstant along a length of the pad.
 18. A respiratory mask according toclaim 15, further comprising: a headgear configured to maintain the facecontact portion in contact with the patient's face and the pad incontact with the patient's forehead.
 19. A respiratory mask according toclaim 15, wherein the face contact portion comprises a mask shellcoupled to a facial cushion support structure including a cheek regionand a nasal bridge region.
 20. A respiratory mask according to claim 19,wherein the facial cushion support structure is configured to encompassthe patient's nose and mouth.